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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO TEAL/CLEAR FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO TEAL/CLEAR FOR TREATMENT PURPOSES Back to Search Results
Model Number MS8929
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient. Medical history included high blood pressure, three heart stents installed and penicillin allergy. Concomitant medications included acarbose and metformin, both for unknown indications. The patient received human insulin isophane suspension(rdna origin) (humulin n 100 u/ml) via reusable pen (humapen ergo teal/clear) subcutaneously, 18 unites each day for the treatment of diabetes mellitus; start date was not provided. She also received another unspecified insulin, subcutaneously, 18 units each morning, 12 unites each noon and 14 units each evening, for the treatment of diabetes mellitus; start date was not provided. On an unspecified date while on human insulin the unspecified insulin treatment, her blood glucose was abnormal and she was hospitalized to regulate it, further information regarding hospitalization dates, laboratory tests findings and corrective treatments was not provided. Also on an unspecified date she adjusted 2 or 3 units more herself to inject insulin via the injection pen due to a device failure (lot number 0511a03/pc number (b)(4)) the outcome of the events was unknown and the dose of the human insulin treatment was adjusted but no further details were provided, the unspecified insulin treatment was continued. The user of the device and his/ her training status was not provided. The device model duration of use and the suspect device duration of use were not reported. The action taken with the suspect device was not provided. The reporting consumer did not know if the events were related to human insulin and did not provide and assessment of relatedness between the unspecified insulin treatment and the events. Update 06sep2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Update 12-sep-2016: information from internal communications received on 01-sep-2016. Pc number (b)(4) was received. Narrative was updated with new information.
 
Manufacturer Narrative
Evaluation summary: a female patient reported her humapen ergo device leaked from the needle after an injection; the patient dialed 2 to 3 units more of insulin due to a suspected device malfunction. The patient experienced abnormal blood glucose levels. The device was not returned to the manufacturer for investigation (batch number 0511a03, manufactured november 2005). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review of the batch did not identify any atypical trends with regard to leaking from the needle after an injection. The duration of use was not provided; however, based on the amount of time elapsed since the device was manufactured (2005), it is likely the patient used the device beyond its approved use life. The humapen ergo user manual states the device was designed to be used for up to 3 years after first use. There is evidence of improper use. It is likely the patient used the device beyond its approved use life. It is unknown if this is relevant to the complaint of abnormal blood glucose levels.
 
Event Description
Lilly case id: (b)(6). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient. Medical history included high blood pressure, three heart stents installed and penicillin allergy. Concomitant medications included acarbose and metformin, both for unknown indications. The patient received human insulin isophane suspension(rdna origin) (humulin n 100 u/ml) via reusable pen (humapen ergo teal/clear) subcutaneously, 18 unites each day for the treatment of diabetes mellitus; start date was not provided. She also received another unspecified insulin, subcutaneously, 18 units each morning, 12 unites each noon and 14 units each evening, for the treatment of diabetes mellitus; start date was not provided. On an unspecified date while on human insulin the unspecified insulin treatment, her blood glucose was abnormal and she was hospitalized to regulate it, further information regarding hospitalization dates, laboratory tests findings and corrective treatments was not provided. Also on an unspecified date she adjusted 2 or 3 units more herself to inject insulin via the injection pen due to a device failure (lot number 0511a03/pc number 3760062) the outcome of the events was unknown and the dose of the human insulin treatment was adjusted but no further details were provided, the unspecified insulin treatment was continued. The user of the device and his/ her training status was not provided. The device model duration of use and the suspect device duration of use were not reported. The action taken with the suspect device was not provided. There was evidence of improper use as the patient used the device beyond its approved use life. The reporting consumer did not know if the events were related to human insulin and did not provide and assessment of relatedness between the unspecified insulin treatment and the events. Update 06sep2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Update 12-sep-2016: information from internal communications received on 01-sep-2016. Pc number (b)(4) was received. Update 11oct2016. Additional information received 11oct2016 from the product complaint safety database. To the device tab added the manufacture date, approximate device age, changed improper use or storage to yes, added the device specific safety summary (dsss), updated the european and (b)(4) device information, updated the device medwatch information, and the narrative was updated accordingly.
 
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Brand NameHUMAPEN ERGO TEAL/CLEAR
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5973375
MDR Text Key55558201
Report Number1819470-2016-00242
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K982842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 08/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS8929
Device Lot Number0511A03
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2016 Patient Sequence Number: 1
Treatment
ACARBOSE; INSULIN HUMAN; METFORMIN
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